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Antiretroviral Therapy

DOR/ISL for HIV/AIDS

Q: Are fresh recruits being sought for the trial?

Affirmative. Clinicaltrials.gov provides evidence that this trial, which was posted on March 17th 2023, is actively recruiting participants right now. The research team aims to recruit 1300 individuals from two distinct sites.

Q: What is the present enrollment for this investigation?

Affirmative, the information posted to clinicaltrials.gov confirms that this trial is currently seeking applicants. The post was published on March 17th 2023 and has since been updated on March 21st of the same year. 1300 patients will need to be enrolled across 2 medical centres for successful completion of this study.

Q: Is the DOR/ISL treatment protocol regarded as secure for patients?

Given the pre-existing data which supports efficacy and multiple rounds of safety assessments, our team at Power assigned DOR/ISL a score of 3 on the 1 to 3 scale.

Q: What are the projected effects of this clinical experiment?

This 96 week research project aims to quantify the number of participants that suffer from adverse events. Secondary targets include measuring <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1 RNA levels at Week 96, and determining any evidence for drug resistance in participant's viral samples.

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 102 weeks

Awards & highlights

Study Summary

This trial will investigate the safety and effectiveness of a drug in HIV-1 patients who have previously used it. No hypotheses are tested.

Who is the study for?

This trial is for adults with HIV-1 who were previously treated with DOR/ISL in certain Merck Sharp & Dohme clinical studies. It's not open to those who are heavily treatment-experienced from other trials.Check my eligibility

What is being tested?

The study is testing the safety and how well people tolerate a combination HIV drug called Doravirine/Islatravir (DOR/ISL). There's no specific hypothesis being tested; it's more about ongoing observation of participants' reactions to the drug.See study design

What are the potential side effects?

While the trial aims to assess safety, potential side effects aren't specified here. Generally, HIV medications can cause issues like nausea, headache, fatigue, and sometimes more serious effects depending on individual health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 102 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 102 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 102 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with One or More Adverse Event (AE)

Percentage of participants who Discontinue Study Intervention Due to an AE

Secondary outcome measures

Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions

Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96

Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96

+1 more

Side effects data

From 2023 Phase 3 trial • 35 Patients • NCT04233216

29%

Diarrhoea

21%

Lymphocyte count decreased

21%

COVID-19

21%

Creatinine renal clearance decreased

14%

Headache

14%

Fatigue

14%

Nausea

14%

Accidental overdose

14%

Rash

Oropharyngeal pain

Alanine aminotransferase increased

Humerus fracture

C-reactive protein increased

Arthralgia

Motor dysfunction

Hypertension

Intermittent claudication

Proteinuria

Sleep terror

Haematuria

Postoperative wound infection

Urinary tract infection

Pancytopenia

Memory impairment

Dry eye

Intestinal transit time increased

Eye irritation

Skin candida

Upper respiratory tract infection

Obesity

Anaemia

Chest pain

Exposure to communicable disease

Abdominal pain

Mitral valve incompetence

Pyrexia

Blood creatine phosphokinase increased

Amoebiasis

Blood calcium increased

Anaemia postoperative

Blood cholesterol increased

Respiratory tract infection viral

Device dislocation

Blood glucose increased

Myelopathy

Cough

Night sweats

Peripheral arterial occlusive disease

100%

80%

60%

40%

20%

Study treatment Arm

DOR+ART

DOR/ISL+ART

Placebo+ART

ISL+ART

Trial Design

1Treatment groups

Experimental Treatment

Group I: DOR/ISLExperimental Treatment1 Intervention

Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOR/ISL

2020

Completed Phase 3

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,887 Previous Clinical Trials

5,054,324 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,214 Total Patients Enrolled

Media Library

DOR/ISL (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05766501 — Phase 3

HIV/AIDS Clinical Trial 2023: DOR/ISL Highlights & Side Effects. Trial Name: NCT05766501 — Phase 3

DOR/ISL (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766501 — Phase 3

HIV/AIDS Patient Testimony for trial: Trial Name: NCT05766501 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh recruits being sought for the trial?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was posted on March 17th 2023, is actively recruiting participants right now. The research team aims to recruit 1300 individuals from two distinct sites."

Answered by AI

What is the present enrollment for this investigation?

"Affirmative, the information posted to clinicaltrials.gov confirms that this trial is currently seeking applicants. The post was published on March 17th 2023 and has since been updated on March 21st of the same year. 1300 patients will need to be enrolled across 2 medical centres for successful completion of this study."

Answered by AI

Is the DOR/ISL treatment protocol regarded as secure for patients?

"Given the pre-existing data which supports efficacy and multiple rounds of safety assessments, our team at Power assigned DOR/ISL a score of 3 on the 1 to 3 scale."

Answered by AI

What are the projected effects of this clinical experiment?

"This 96 week research project aims to quantify the number of participants that suffer from adverse events. Secondary targets include measuring HIV-1 RNA levels at Week 96, and determining any evidence for drug resistance in participant's viral samples."

Answered by AI

Who else is applying?

What state do they live in?

Florida

Texas

Virginia

What site did they apply to?

Therafirst Medical Center ( Site 3110)

The Crofoot Research Center ( Site 3101)

Georgetown University Medical Center ( Site 3130)

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I want to try different drugs. I am interested and I believe in the development of new drugs that can help myself and promote a safety and healthy way to live even having medical conditions.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

2023. "A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766501.

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